联席主承销商：国信证券股份有限公司 广州必贝特医药股份有限公司 保荐人（主承销商）：中信证券股份有限公司 必贝特是一家以临床价值为导向、专注于创新药自主研发的生物医药企业。 必贝特实际控制人为钱长庚，无控股股东。截至招股意向书签署日，钱长庚直接持有必贝特15.2840%的股份，是必贝特的第一大股东，同时通 过担任广州药擎执行事务合伙人控制必贝特8.5899%的股份。 钱长庚，1955年出生，美国国籍，拥有中国境内永久居留权。 发行情况： | | 股票代码 | 688759 | 股票简称 | 必见特 | | --- | --- | --- | --- | --- | | | 申购代码 | eastmoney 787759 | 上市地点 | 上海证券交易所科创板 om | | | 发行价格(元假) | 17.78 | 友行市盈率 | | | | 市需率参考行业 | 医药制造业 | 参考行业市盈率(最新) | 31.83 | | | 友行面值(元) | 1 | 买际要集资 高额(亿元) | 16.00 | | 发行状况 | 网上发行日期 | 2025-10-17 (周五) | 网下配售目期 | 2025-10-17 ...

Core Viewpoint - AskGene Pharma has entered into a licensing agreement with Visara, allowing Visara to commercialize the innovative drug project ASK712, which targets both VEGF and ANG-2 for the treatment of retinal diseases [1][2] Group 1: Licensing Agreement - The licensing agreement enables the development and commercialization of the ASK712 project in the licensed area, which is expected to positively impact the company's future performance [2] - This agreement aligns with the company's strategic focus on innovative drug development in areas such as digestion, oncology, anti-infection, and chronic diseases [2] Group 2: Drug Development - ASK712 is a first-class innovative drug developed by AskGene Pharma, currently in the IIa clinical research phase in China [1] - Clinical results from the I phase show that ASK712 has good safety and efficacy, with preclinical data indicating stronger binding activity to VEGF and ANG-2 compared to existing treatments [1]

Core Viewpoint - AskGene Pharma has entered into a licensing agreement with Visara for its innovative drug project ASK712, which targets both VEGF and ANG-2, indicating a strategic move towards enhancing its research and commercialization efforts in the therapeutic area of eye diseases [1][2] Group 1: Licensing Agreement - AskGene Pharma has licensed its proprietary rights for the innovative drug ASK712 to Visara, which is expected to facilitate the development and commercialization of the drug in the licensed area [1] - The licensing agreement aligns with the company's strategic focus on innovation in drug development, particularly in areas such as digestion, oncology, anti-infection, and chronic diseases [2] Group 2: Drug Development and Clinical Trials - ASK712 is currently in the Phase IIa clinical trial stage in China, demonstrating good safety and efficacy based on Phase I dose escalation and expansion results [1] - Preclinical data suggests that ASK712 has a stronger binding affinity for VEGF and ANG-2 compared to existing treatments, potentially improving efficacy and extending dosing intervals, which may enhance patient compliance [1]

Group 1: New Stock Subscription - Bibet - Bibet (688759.SH) is a biopharmaceutical company focused on innovative drug development, particularly in oncology, autoimmune diseases, and metabolic diseases [1][4] - The company has a market capitalization of 6.401 billion yuan and an issue price of 17.78 yuan per share, with an expected price-to-earnings ratio of 31.83 [4] - Bibet's research pipeline includes one approved innovative drug, BEBT-908, and several others in various clinical trial phases, with a significant focus on unmet clinical needs [5][6][7] Group 2: Financial Performance and Funding - Bibet has reported net losses of 0.0188 billion yuan, 0.0173 billion yuan, and 0.0056 billion yuan over the past three years, indicating ongoing financial challenges [8] - The company plans to allocate 9.49 billion yuan (47.35%) of its raised funds to new drug research and development, 5.55 billion yuan (27.71%) to the construction of a research center, and 5.00 billion yuan (24.94%) for working capital [4] Group 3: New Stock Listing - Daosheng Tianhe - Daosheng Tianhe (601026.SH) is a national high-tech enterprise specializing in the research, production, and sales of new materials, particularly epoxy resins and polyurethane [1][11] - The company has a market capitalization of 3.943 billion yuan and an issue price of 5.98 yuan per share, with a price-to-earnings ratio of 29.05 [11] - Daosheng Tianhe is recognized as a leading supplier of materials for wind turbine blades and has established stable relationships with major industry players [14][15] Group 4: Financial Performance and Market Position - Daosheng Tianhe's revenue for 2022, 2023, and 2024 was 3.436 billion yuan, 3.202 billion yuan, and 3.238 billion yuan, with net profits of 0.11 billion yuan, 0.155 billion yuan, and 0.155 billion yuan respectively [15] - The company has been recognized as a national-level "little giant" enterprise and has obtained 69 patents, including 38 invention patents [15]

Core Insights - Beijing is leading in the development and approval of innovative drugs, with significant reforms in the pharmaceutical and medical device regulatory framework to promote high-quality development in the industry [2][3][4] Group 1: Innovative Drug Development - Beijing is the first city in China with a pharmaceutical and health industry exceeding 10 trillion yuan, hosting 12,000 medical institutions and over 80 clinical trial institutions, accounting for one-third of national clinical trial projects [2] - The city has a strong foundation for innovative drug research, with approximately 40% of national life sciences research outcomes originating from Beijing [2][3] - The number of innovative drug projects in Beijing consistently ranks first in the country, with thousands of international multi-center clinical trials conducted annually [2][3] Group 2: Clinical Trial Efficiency - The National Medical Products Administration (NMPA) has launched a pilot program to optimize the review and approval process for innovative drug clinical trials, with Beijing selected as a trial region [4] - In the pilot program, 14 innovative drug projects were guided by the Beijing Drug Administration, achieving a 100% approval rate for clinical trials, with an average review time of 24.6 working days [4] - The efficiency of clinical trial initiation has significantly improved, with the time from approval to initiation reduced to an average of 5 weeks, and some projects initiated in as little as one week [4] Group 3: Import and Accessibility of Innovative Drugs - The import of innovative drugs has been facilitated by expedited customs processes, with Beijing's import of pharmaceutical materials and drugs reaching 748.44 billion yuan from January to August, accounting for 32.2% of the national total [6] - The import value of rare disease drugs in Beijing reached 2.66 billion yuan, marking a 59.1% increase, making it the highest in the country [6] - The dual-channel mechanism for newly approved drugs ensures better accessibility for patients, with the average time from drug approval to inclusion in the medical insurance directory reduced from 5 years to about 1 year [7] Group 4: Supportive Policies and Future Directions - The Beijing government has implemented a series of supportive measures for innovative drug development, including the "32 measures" and a three-year action plan for collaborative innovation in the pharmaceutical sector [3][7] - The city aims to continue enhancing the synergy between technology and the healthcare system, focusing on comprehensive services, policies, funding, and talent to foster an internationally competitive industry ecosystem [7]

Core Viewpoint - The company Bibeite (688759.SH) has initiated its subscription with an issue price of 17.78 yuan per share, focusing on innovative drug development for major diseases such as cancer and autoimmune disorders [1]. Company Overview - Bibeite is a biopharmaceutical company that emphasizes clinical value and is dedicated to the independent research and development of innovative drugs [1]. - The company has one approved breakthrough therapy drug, BEBT-908, for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) and several other products in various stages of clinical trials [1][2]. Product Pipeline - BEBT-908 is the first-in-class small molecule dual-target inhibitor designed for HDAC/PI3Kα, approved for multiple hematologic malignancies and solid tumors [1]. - Other products include: - BEBT-209, currently in Phase III clinical trials [1]. - BEBT-109, which has been approved to start Phase III clinical trials [1]. - Five additional products are in Phase I clinical trials, and several more are in preclinical research [1][3]. Financial Performance - The company reported net losses of approximately 188 million yuan in 2022, 173 million yuan in 2023, and an expected loss of 55.998 million yuan in 2024 [4]. - Bibeite has not yet achieved profitability and anticipates significant ongoing research and development expenditures, which will likely prevent any profit distribution or cash dividends in the short term [4]. Financial Metrics - Total assets as of December 31, 2024, are projected to be 332.4771 million yuan, down from 441.8725 million yuan in 2023 and 587.2168 million yuan in 2022 [4]. - The company's equity attributable to shareholders is expected to be 290.2201 million yuan in 2024, compared to 318.1196 million yuan in 2023 and 468.3349 million yuan in 2022 [4]. - The debt-to-asset ratio for the parent company is projected to be 12.38% in 2024, a decrease from 27.77% in 2023 and 20.23% in 2022 [4].

Company Overview - Guangzhou Bibetter Pharmaceutical Co., Ltd. is a biopharmaceutical company established in 2012, focusing on innovative drug research and development with a clinical value orientation [4] - The company specializes in major disease areas such as tumors and metabolic diseases, leveraging its core technology platform for continuous development of first-in-class drugs and innovative medicines addressing unmet clinical needs [4][11] Research and Development Pipeline - The company has established a diverse and differentiated R&D pipeline, having obtained over 30 clinical approvals, with one class 1 innovative drug already on the market and two others in phase III clinical trials [5][21] - The core product, BEBT-908, is a globally first-in-class HDAC/PI3Kα dual-target anti-tumor drug, approved for treating relapsed or refractory diffuse large B-cell lymphoma, with other indications in phase II clinical trials [5][25] - The company is also focusing on next-generation small nucleic acid (siRNA) drug development, having established three proprietary delivery systems with global intellectual property rights [6][22] Financials and Investment - The company has invested significantly in R&D, with expenditures of approximately 166.74 million yuan in 2022, 157.65 million yuan in 2023, and projected 120.29 million yuan in 2024 [17] - The funds raised from the IPO will primarily be used to accelerate the clinical progress of the R&D pipeline, enhance commercialization capabilities, and expand the product line [26][30] Market Position and Strategy - The company aims to become a globally influential innovative drug developer in major disease areas, focusing on deepening independent R&D, accelerating commercialization, and expanding into global markets [19] - The competitive advantages include innovation-driven development, strong R&D capabilities, a broad product pipeline, and significant market potential for approved and core products [20][25] Regulatory Environment - The implementation of the drug marketing authorization holder (MAH) system is seen as a favorable policy for the company, allowing it to focus resources on core R&D activities [25] - The company meets the listing standards for the Sci-Tech Innovation Board, having at least one core product approved for clinical trials and a projected market value of no less than 4 billion yuan [28][29]

Investment Rating - The report initiates coverage with a "Buy" rating for the company [29] Core Insights - The company is set to commercialize its second-generation ALK inhibitor, SY-707, and has promising clinical value for its third-generation ALK inhibitor, SY-3505, which is expected to capture a significant market share [4][10][21] - The company has a differentiated pipeline of innovative drugs, focusing on ALK mutation NSCLC, with several candidates showing strong clinical efficacy and safety profiles [5][22] - Revenue projections for 2025 to 2027 are estimated at 0.15 billion, 0.96 billion, and 2.85 billion yuan, with growth rates of 280.5%, 537.7%, and 197.8% respectively [29] Summary by Sections 1. Profit Forecast - Revenue is projected to be 0.04 billion yuan in 2024, increasing to 0.15 billion in 2025, 0.96 billion in 2026, and 2.85 billion in 2027, with respective growth rates of -24.6%, 280.5%, 537.7%, and 197.8% [2][29] - Net profit attributable to shareholders is forecasted to be -2.12 billion yuan in 2024, -1.83 billion in 2025, -2.08 billion in 2026, and -1.12 billion in 2027 [2][29] - The earnings per share (EPS) is expected to improve from -1.43 yuan in 2024 to -0.75 yuan in 2027 [2][29] 2. Innovative Drug Pipeline - The company has multiple differentiated innovative drug candidates, including SY-707 (a second-generation ALK inhibitor) and SY-3505 (a third-generation ALK inhibitor), both targeting ALK-positive NSCLC [5][10] - SY-5007, a selective RET inhibitor, is expected to submit a New Drug Application (NDA) in the second half of 2025, showing strong clinical efficacy compared to existing treatments [22][23] - SY-5933, a KRAS (G12C) inhibitor, has demonstrated significant anti-tumor activity in early clinical trials, with a focus on combination therapies [24][28] 3. Market Position and Competitive Advantage - The company is positioned to capture market share in the ALK-TKI market with its innovative therapies, particularly with the anticipated approval of SY-707 and the promising clinical data for SY-3505 [10][21] - The report highlights the competitive advantages of SY-5007 and SY-5933 in terms of clinical efficacy and safety compared to existing therapies [22][24]

Core Insights - Beijing's pharmaceutical regulatory reforms are significantly enhancing the efficiency of drug approval processes, transitioning from "people waiting for drugs" to "drugs waiting for people" [1][2] - The introduction of a series of innovative policies, including the establishment of a rare disease drug guarantee zone and expedited clinical trial approvals, is expected to stimulate industry growth [1][2] Regulatory Reforms - Six groundbreaking reforms have been implemented in Beijing, including optimizing clinical trial review processes and establishing a pilot for segmented production of biological products [1][2] - The approval time for clinical trials has been reduced from 60 working days to as fast as 18 working days, with 14 projects currently in the pilot program [2] - A total of 26 drug varieties have been approved under the rare disease drug guarantee initiative, benefiting over 4,900 patients [2] Inspection and Testing Capabilities - Beijing has maintained its leading position in the number of vaccine batch release authorizations among provincial drug inspection agencies [1][6] - The Beijing Vaccine Inspection Center is expected to be operational by the end of this year, capable of meeting the annual inspection demand for 4,000 vaccine batches [1][6] Innovation and Development - A total of 324 innovative products have been included in key project management, accelerating the transition from research and development to market approval [5] - The average review time for first-time medical device registrations has been reduced to 45 working days, a 63% improvement over the statutory limit [5] Service Optimization - The establishment of a green channel for the inspection and testing of urgently needed medical devices has been achieved, with 20 batches of 10 specifications already inspected [6] - The implementation of a fully electronic review and approval system for second-class medical devices has streamlined the registration process [5][6]

Group 1 - The Hong Kong Stock Connect innovative drug sector experienced a rapid surge, with the high-elasticity Hong Kong Stock Connect innovative drug ETF (520880) rising over 3.6% and achieving a transaction volume exceeding 260 million yuan [1] - The ETF had a significant rebound of 2.12% the previous day, with a total of 130 million yuan attracted over four consecutive days, indicating a warming capital environment [1] - Huachuang Securities noted a shift in the innovative drug industry from quantity logic to quality logic, predicting a product-centric phase by 2025, with domestic innovative drug companies' differentiated pipelines and international layouts becoming crucial [1] Group 2 - The Hong Kong Stock Connect innovative drug ETF (520880) passively tracks the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, which currently excludes CXO and focuses entirely on innovative drug R&D companies [1] - As of the end of September, the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index had a year-to-date increase of 108.14%, outperforming other innovative drug indices [1] - The ETF is the first in the market to track the aforementioned index, with a fund size of 1.806 billion yuan and an average daily transaction volume of 493 million yuan since its listing, making it the largest and most liquid ETF in its category [1]